Aripiprazole of formula (1):
or 7-[4-[4-(2,3-Dichlorophenyl)-1-piperazinyl]butoxy]-3,4-dihydro-2(1H)-quinolinone and its salts are useful for treating schizophrenia and their therapeutic uses were disclosed in U.S. Pat. No. 5,006,528.
Processes for the preparation of aripiprazole and its salts were described in U.S. Pat. No. 5,006,528. These processes do not produce well defined, reproducible crystalline forms.
Thus there is a need for stable and reproducible crystalline forms of aripiprazole and its salts.
We have discovered two novel crystalline forms of aripiprazole and four novel crystalline forms of aripiprazole hydrochloride. The novel forms have been found to be stable over the time and reproducible and so, suitable for pharmaceutical preparations.
Thus, the object of the present invention is to provide stable novel crystalline forms of aripiprazole, processes for preparation of the novel crystalline forms and pharmaceutical compositions containing these novel crystalline forms.
Another object of the present invention is to provide stable novel crystalline forms of aripiprazole hydrochloride, processes for preparation of the novel crystalline forms and pharmaceutical compositions containing these novel crystalline forms.
Since the novel crystalline forms of aripiprazole hydrochloride are obtained with high purity, preparation of aripiprazole via the crystalline forms of aripiprazole hydrochloride serves as a means of producing pure aripiprazole.